My report on my discussions before and after the ASM. An audio file of the actual meeting was posted earlier.
I spoke with Dr. Kendall, Garrett Ingram, and Rose Alinaya after the meeting and one of the engineers before the meeting. Below is a summary of what I discussed with each to the best of my memory.
Engineer, sorry but I didn’t write his name down.
1. Is refrigeration really required? Yes because of the way the FDA defines potency. He agreed that the product may be effective even if left in a hot car for months, but in order to meet the requirements set by the FDA, Afrezza needs to be refrigerated to maintain its potency throughout it’s expiration date. He did say that they are challenging the expiration date requirement with the FDA based on when the powder is created vs when the cartridges are filled and packaged. If successful, the finished product would have a longer shelf life. He was also showing off Bluehale and I asked if each PAH patient would need one and he said probably only in the learning phase but couldn’t say for sure.
2. Dr. Kendall
I told him about my T1 friend on a pump being told by her endo that Afrezza is not as precise in dosing as her pump so it’s not for her or his other patients on a pump. He wasn’t surprised and that is the challenge he sees all the time.
He and Mike met with the Cornell medical team, at Cornell’s request, on Monday, the day before the meeting. They wanted to know more about Afrezza.
I told him that the shareholders thought he was our savior since he was the CMO at the ADA. Then he said it was a very bureaucratic organization and slow to change and that’s why he left. But he is good friends with the current CMO and they talk about Afrezza.
I asked if a 2U cartridge was necessary. He said probably yes for a very few adult patients but knows that users have been using 4Us to make 2Us. They are waiting to see if it is necessary to produce as a result of the Pediatrics trial. I asked if the Peds trial can be expedited and he said no but there is a person in the organization who’s the point person for the trials. He was surprised at how long it’s taken to get the kids enrolled because of cautious parents. He did say that there was an early status of the Pediatrics trial that would be shared at the ADA. He also cautioned that kids have much more variability than adults, more difficult to dose properly.
3. Garrett Ingram
We talked about the new sales brochures and messaging for the reps and she showed them to me. We should be able to see them on Afrezza web site now.
She has 4 kids and two are T1. They are users of Afrezza but I don’t remember if she mentioned their ages. She used to work on Novolog before coming to MNKD.
We talked about the TV commercial and the new print ad with the needles. She knows the commercial was effective in driving people to the website to learn more and downloading the co-pay cards. But now that the TV ads have stopped, the traffic has dropped off dramatically. She is open to ideas for a new commercial but did not say that they will be producing a new one any time soon. I told her that the share holders want to see disruptive ads, like the human pin cushion, the girl with all the needles. She told me to send ideas and they would consider them. So if you have ideas, send them to her: gingram@mannkindcorp.com
I got a promo inhaler and empty cartridges at the meeting and told her that shareholders would love to have them so they can demonstrate when talking to friends and families. She had no problem with shareholders receiving them but didn’t have a way to distribute them. They give them out at any event they attend.
I asked how successful the cash pay, Eagle program was going. She said she didn’t have the numbers on that. I think she was dogging on that one.
4. Rose Alinaya
I interrupted her while she was eating her lunch but she graciously set it aside and talked to me for 30 minutes. Since she used to be the controller, I asked her a variety of questions.
I asked if they considered paying off Deerfield early. It was discussed but deemed not necessary and they will be “paid” off in July. Deerfield debt is NOT impacting any current partnering discussions but until the debt is repaid, there can’t be additional debt raised.
I told her how demoralizing the last dilution in Dec was for most shareholders. She was sympathetic and said management is aware and will prevent it if at all possible. I said the share authorization last year was supposed to last for three years but we’ve used most of them in just one year. She just nodded, what else could she do.
I said most shareholders want to see more communications coming from the company and that Mike and team should have more frequent shareholder webcasts to inform us of what’s going on. Also a better use of social media to promote Afrezza.
I asked about the Indy Car sponsorship and how could we afford that ?? $1M ??. She corrected me and said it was much less than $1M, but didn’t give a number. I asked if there was going to be any other promotional activities with Connor or the race team and she didn’t know. I asked if there was any significance with “Mannkind Diabetes” on the car vs Afrezza. She said they couldn’t use Afrezza because of the black box warning and the required disclosures. Tribesa, Fiasap, and Viagra do not have black box warnings.
I did not get to speak to Mike since he had to attend the BOD meeting.
Florida is half way around the world for me.